Argentina's ANMAT approves over‑the‑counter sales for ten drug groups
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) issued Disposition 4714/2026, published in the Official Gazette, authorising ten active‑ingredient groups to be sold without a prescription. The measure follows the Ministry of Health’s Resolution 284/2024, which tasked ANMAT with reviewing OTC eligibility. To qualify, each drug must have been marketed for at least five years under prescription, demonstrated safety and efficacy, a wide therapeutic margin and no serious adverse events. The authorised ingredients include trimebutine maleate, levocetirizine, fexofenadine, dimenhydrinate, a nafazolina + feniramina combination, olopatadine, carbocisteine, aluminum chloride hexahydrate, a calcium‑carbonate‑arnica‑silver‑nitrate blend, and topical ivermectin (0.5 % lotion). Existing stock may continue to be sold with current labelling; new batches must carry a QR code and updated labelling linking to a digital prospectus.
Professional bodies voiced concerns: the Colegio de Farmacéuticos de la Provincia de Buenos Aires (COLFARMA) warned of health‑risk and safety issues, and Pablo Yáñez, president of the Santa Cruz pharmacists’ college, called the change a risk for patients. Conversely, merchants in San Juan expressed strong support, citing commercial opportunity and consumer convenience. The regulation applies only to the specific concentrations, forms and routes of administration detailed in the disposition.
Entities: ARCSA · Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) · Argentina · Colegio de Farmacéuticos de la Provincia de Buenos Aires (COLFARMA) · Daniel Noboa · Eduardo Midence · India · Ministerio de Salud de la República Argentina · Ministry of Health · Nasry Asfura · Pablo Yáñez · San Juan retail merchants
Claims
What the coverage asserts, and how well corroborated each claim is across sources.
- [● 3 SOURCES] The measure follows the Ministry of Health's Resolution 284/2024, which tasked ANMAT with reviewing OTC eligibility.
- [● 5 SOURCES] The regulation applies only to the specific concentrations, pharmaceutical forms and routes of administration defined in the disposition.
- [● 2 SOURCES] Existing stock can continue to be sold with current labelling; new batches must carry a QR code and updated labelling linking to a digital prospectus.
- [● 11 SOURCES] The authorised active ingredients are trimebutine maleate, levocetirizine, fexofenadine, dimenhydrinate, nafazolina + feniramina, olopatadine, carbocisteine, aluminum chloride hexahydrate, calcium‑car
- [○ 1 SOURCE] Merchants in San Juan supported the policy, saying over‑the‑counter sales in kiosks would boost profitability and convenience for customers.
- [● 6 SOURCES] ANMAT issued Disposition 4714/2026 authorising ten active ingredients to be sold without a prescription. (cb00076a-7683-407e-a082-ccab9fce44e9, e27bc06b-f9e8-4c98-bd79-35438d05eb86, a2ae42b8-20be-4c91-b671-ad2fe101b0f9, e305d-)
- [● 4 SOURCES] To qualify, a drug must have shown safety, efficacy, a wide therapeutic margin and at least five years of prescription‑only marketing without serious adverse events.
- [● 2 SOURCES] Pharmacy professional groups, including COLFARMA and the Santa Cruz pharmacists’ college, warned that the OTC expansion poses safety risks for patients.
- [● 12 SOURCES] ANMAT authorized over‑the‑counter sale of ten drug groups through Disposition 4714/2026.
- [○ 1 SOURCE] Retailers in San Juan largely support the policy, citing increased sales and consumer convenience.